Bodily fluid drainage assembly

ABSTRACT

A bodily fluid drainage assembly can include a fluid bag and one or more covers. The assembly can include one or more volume indicators from which an approximate volume of a bodily fluid that is retained within the be can be ascertained. In some arrangements, a cover includes a volume indicator that defines an opening through which a transparent or semitransparent portion of the bag can be viewed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of pending U.S. patentapplication Ser. No. 16/773,611, filed on Jan. 27, 2020, which is acontinuation of pending U.S. patent application Ser. No. 14/444,271,filed on Jul. 28, 2014, which is a continuation of U.S. patentapplication Ser. No. 13/088,409, filed on Apr. 17, 2011, which issued asU.S. Pat. No. 8,790,320 on Jul. 29, 2014, which is acontinuation-in-part of U.S. patent application Ser. No. 12/253,714,filed on Oct. 17, 2008, which issued as U.S. Pat. No. 8,092,436 on Jan.10, 2012, and is also a continuation-in-part of InternationalApplication No. PCT/US2009/059482, which has an international filingdate of Oct. 5, 2009, was published as International Publication No. WO2010/045042, and claims priority to: U.S. Provisional Patent ApplicationNo. 61/143,327, filed on Jan. 8, 2009; U.S. Provisional PatentApplication No. 61/184,240, filed on Jun. 4, 2009; and U.S. patentapplication Ser. No. 12/253,714, filed on Oct. 17, 2008. The entirecontents of each of the foregoing applications and patents are herebyincorporated by reference herein.

TECHNICAL FIELD

The present disclosure relates generally to the field of medicaldevices. More specifically, the present disclosure relates to bodilyfluid drainage assemblies.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments will become more fully apparent from thefollowing description and appended claims, taken in conjunction with theaccompanying drawings. Understanding that the accompanying drawingsdepict only typical embodiments, and are, therefore, not to beconsidered to be limiting of the disclosure's scope, the embodimentswill be described and explained with specificity and detail in referenceto the accompanying drawings.

FIG. 1 is an exploded perspective view of a bodily fluid drainageassembly.

FIG. 2 is a perspective view of the bodily fluid drainage assembly ofFIG. 1 after the assembly has been assembled.

FIG. 3A is a front elevation view of the bodily fluid drainage assemblyof FIG. 1 before the bodily fluid drainage assembly has received anyfluid.

FIG. 3B is a front elevation view of the bodily fluid drainage assemblyof FIG. 3A after the bodily fluid drainage assembly has received somefluid.

FIG. 3C is a front elevation view of the bodily fluid drainage assemblyof FIG. 3A after the bodily fluid drainage assembly has receivedadditional fluid.

FIG. 3D is a front elevation view of the bodily fluid drainage assemblyof FIG. 3A after a portion of the bodily fluid drainage assembly hasbeen torn.

FIG. 4A is a front elevation view of another embodiment of a bodilyfluid drainage assembly.

FIG. 4B is a front elevation view of the bodily fluid drainage assemblyof FIG. 4A after the assembly has received some fluid.

FIG. 4C is a front elevation view of the bodily fluid drainage assemblyof FIG. 4B after a portion of the assembly has been torn.

FIG. 4D is a front elevation view of the bodily fluid drainage assemblyof FIG. 4C after a portion of the assembly has been removed.

FIG. 5A is a front elevation view of another embodiment of a bodilyfluid drainage assembly.

FIG. 5B is a front elevation view of the assembly of FIG. 5A after theassembly has received some fluid.

FIG. 5C is a front elevation view of the assembly of FIG. 5B after aportion of the assembly has been removed.

FIG. 6 is a front elevation view of another embodiment of a bodily fluiddrainage assembly.

FIG. 7 is a front elevation view of another embodiment of a bodily fluid

FIG. 8 is a front elevation view of another embodiment of a bodily fluiddrainage assembly.

FIG. 9 is a front elevation view of another embodiment of a bodily fluiddrainage assembly.

FIG. 10 is a front elevation view of another embodiment of a bodilyfluid drainage assembly.

FIG. 11 is a front elevation view of the bodily fluid drainage assemblyof FIG. 10 after fluid-obscuring flaps have been raised.

FIG. 12 is a front elevation view of another embodiment of a bodilyfluid drainage assembly.

FIG. 13 is a perspective view of another embodiment of a bodily fluiddrainage assembly, wherein a cover is partially lifted.

FIG. 14 is a perspective view of the bodily fluid drainage assembly ofFIG. 13, wherein the cover is not lifted.

FIG. 15 is a front elevation view of the cover of the bodily fluiddrainage assembly of FIG. 13.

FIG. 16 is a side elevation view of the cover of the bodily fluiddrainage assembly of FIG. 13.

FIG. 17 is a perspective view of another embodiment of a bodily fluiddrainage bag assembly with a fluid bag thereof in an empty or pre-usestate and a cover thereof in an obscuring orientation.

FIG. 18 is a perspective view of the bodily fluid drainage bag assemblyof FIG. 17 with the fluid bag thereof in the pre-use state and the coverthereof in a viewing orientation.

FIG. 19 is a front elevation view of the bodily fluid drainage bagassembly of FIG. 17 with the fluid bag thereof in a partially filledstate and the cover thereof in the obscuring orientation.

FIG. 20 is a side elevation view of the bodily fluid drainage bagassembly of FIG. 17 shown in the same operational state as that in FIG.19.

FIG. 21 is a front elevation view of another embodiment of a bodilyfluid drainage bag assembly that includes a pleated cover.

FIG. 22 is a side elevation view of the bodily fluid drainage bagassembly of FIG. 21 with a fluid bag thereof in a partially filled stateand the cover thereof in an obscuring orientation.

FIG. 23 is a front elevation view of another embodiment of a drainagebag assembly shown in a pre-use state.

DETAILED DESCRIPTION

It will be readily understood that the components of the embodiments asgenerally described and illustrated in the figures herein could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thedisclosure, as claimed, but is merely representative of variousembodiments. While the various aspects of the embodiments are presentedin drawings, the drawings are not necessarily drawn to scale unlessspecifically indicated.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be coupled to each other even thoughthey are not in direct contact with each other. The term “abutting”refers to items that are in direct physical contact with each other,although the items may not necessarily be attached together.

FIGS. 1-2 depict a bodily fluid drainage assembly 100, from front views,wherein FIG. 1 is an exploded-perspective view and FIG. 2 is aperspective view after the assembly has been assembled. Bodily fluiddrainage assembly 100 may comprise a fluid bag 110, a first cover 130and a second cover 140. Assembly 100 is configured to receive bodilyfluid; optionally retain the fluid; at least partially obscure thevisibility of the fluid while allowing an approximate volume of thefluid to be determined; and optionally allow the fluid to be directlyviewed by at least partially removing a portion of the assembly.Drainage bag 110 and first and second covers 130, 140 may comprisepolyvinyl chloride, polyurethane, vinyl or any other suitable material.In some embodiments, one or more of the drainage bag 110 and the firstand second covers 130, 140 may comprise the same material, whereas inother embodiments, one or more of the drainage bag 110 and the first andsecond covers 130, 140 may comprise different materials.

Drainage bag 110 may comprise one or more panels 112 of one or moreliquid impervious materials. At least a portion of the front panel 112can be substantially transparent or semitransparent such that a liquidcontained within the bag may be readily observed. The panels 112 may bejoined along an outer edge 111 thereof via radio frequency (RF) welding,heat sealing, gluing, or any other suitable technique. Once joined, thetwo panels comprise a seam 113 adjacent to outer edge 111. When coupledtogether, the panels 112 form a fillable void that may receive fluid viaan inlet tube 121 and a corresponding inlet aperture (not visible) thatare located on upper portion 115 of bag 110. Approximate volume of fluidwithin the bag 110 may be ascertained via a first volume indicator 117,which may comprise marks or graduations 118 on front panel 112 of bag110. In the depicted embodiment, graduations 118 denote variouspredetermined volumes and may be printed on the fluid bag. In anotherembodiment, the graduations 118 may comprise raised or recessed portionsof the fluid bag that are formed during or after manufacturing of thefluid bag. The graduations 118 may represent any predeterminedmeasurement of volume, such as fluid ounces and/or milliliters, and mayvary in their relative distributions accordingly. In some embodiments,the space between sequential graduations 118 may not be uniform in scaleso as to account for a non-linear rate of rise in fluid level, such asmay result from expansion of the fluid bag 110 as the bag fills withliquid and/or from a transverse dimension of the bag 110 that varieswith a height of the bag. In the depicted embodiment, graduations 118are located on a left portion (as seen from the viewer's perspective) offluid bag 110; however, in other embodiments, the graduations may belocated at any suitable location on fluid bag 110. Stated otherwise, inthe illustrated embodiment, the first volume indicator 117 extendsupwardly and at a leftward slanting angle. Since at least a portion offront panel 112 is transparent or semitransparent (e.g., translucent),the top of the fluid can be compared to the graduations 118 to therebydetermine the volume of the fluid, or the approximate volume thereof.

A variety of types and configurations of fluid bags can be utilizedwithout departing from the scope and spirit of the present disclosure.For example, the fluid bag may be manufactured using a one-piece method,wherein the bag comprises a single piece of plastic that is folded alongone or more edges and, further, is sealed to itself or otherwise closedalong one or more edges. Further, the shape and size of assembly 100 isprimarily for illustrative purposes and may vary.

A hanger 124 can be located at an upper portion 115 of the fluid bag110, such as within a non-fillable region 125 of the fluid bag 110. Forexample, in the illustrated embodiment, a base region 126 of the hanger124 can be positioned within the non-fillable region 125 of the fluidbag 110 (e.g., a region that is not configured to be filled with fluidsfrom a patient) and can be retained in this position by the portions ofthe seam 113 that define the edges of the non-fillable region 125. Insome embodiments, the base region 126 of the hanger 124 is placedbetween the front and rear panels 112 prior to formation of the seam113, and the seam 113 is thereafter formed so as to encompass the baseregion 126 of the hanger 124. In other embodiments, the base region 126of the hanger 124 may be inserted into a previously formed non-fillableregion 125.

Hanger 124 can be configured to allow assembly 100 to be suspended froma patient, or from a nearby structure, such as a wheelchair, bed, orstand. Hanger 124 may comprise one or more hook-like extensions, one ormore apertures, or both. The hanger 124 may comprise one or more piecesof plastic, and in some embodiments, may be fixedly coupled to assembly100 via RF welding, heat sealing, gluing, hardware, or any othersuitable technique. In other embodiments, hanger 124 may be coupled toassembly 100 such that it may be selectively removed from the fluid bag110. In other embodiments, hanger 124 may comprise an aperture in bag110 and/or first and second covers 130 and 140. Still other arrangementsof the hanger 124 are possible.

An outlet tube 122 and corresponding drainage bag outlet aperture (notvisible) are located at the bottom portion 116 of the fluid bag 110. Theoutlet tube 122 may allow a fluid contained within the fluid bag 110 tobe drained from the bag or retained within the bag via an outputregulator 123. Output regulator 123 may comprise a plastic or metalclip, in-line valve, or any other suitable structure. Fluid bag 110 mayfurther comprise an outlet tube holder 114 that comprises a slot, loop,or hook that is configured to receive and reversibly retain outlet tube122 in an at least partially upright position. For example, in theillustrated embodiment, the outlet tube holder 114 comprises a plasticpiece that projects forwardly from the fluid bag 110 so as to define acavity. When the assembly 100 is in a packaged or pre-use state, abottom end of the outlet tube 122 can be positioned within the cavity ofthe outlet tube holder 114. The outlet tube 122 can be removed from theholder 144 and allowed to hang downwardly into the positions shown inFIGS. 1 and 2 during use of the assembly 100.

As will be determined by those skilled in the art, a variety of typesand configurations of bodily fluid drainage bags can be utilized withoutdeparting from the scope and spirit of the present disclosure. Forexample, the size, shape, and proportions of the fluid bag may vary(see, e.g., FIGS. 6-9). Additionally, the size, shape, and proportionsof the inlet and outlet tubes, as well as the materials from which thefluid bag and tubes are manufactured may vary. For example, in someembodiments, the hanger comprises a contiguous extension of the bag,whereas in other embodiments, the hanger comprises an aperture in thebag.

Bodily fluid drainage assembly 100 may further comprise a first cover130 that can be formed from or otherwise include an opaque material (orat least partially opaque material capable of obscuring the appearanceof a fluid positioned at one side thereof), and which may define asimilar shape as fluid drainage bag 110. First cover 130 has an outeredge 131 that may be at least partially aligned with outer edge 111 offluid bag 110. However, at least a portion of the outer edge 131 of thefirst cover 130 may extend outwardly beyond the outer edge 111 of thefluid drainage bag 110. When first cover 130 is coupled to bag 110, aseam 133 may be formed along (e.g., at or near) outer edge 111. Thefirst cover may be coupled to the fluid drainage bag via RF welding,heat sealing, gluing, hardware, or any other suitable technique. Firstcover 130 may be coupled to bag 110 only along (e.g., at or near) outeredge 131, or in other embodiments, the first cover 130 can be coupled tothe bag 110 along more than one edge.

In the illustrated embodiment, the cover 130 further comprisesperforations 134 that are located adjacent to seam 133 and areconfigured to allow cover 130 to be at least partially removed from bag110. The perforations 134 may thus define a region of weakness. In otherembodiments, the seam 133 itself, or a portion of the first cover 130that borders the seam 133, may define a region of weakness for the cover130 (i.e., a region at which the cover 130 is weaker than neighboringportions thereof), such that the cover 130 may be removed from the bag110 generally along the line or contour of the seam 133. Other suitablemethods and systems for removing the cover 130 are also possible.

First cover 130 further comprises an interior edge 132 that may have anotch or cutout 138 that partially surrounds the junction of inlet tube121 and fluid bag 110. A second volume indicator 135 is located on firstcover 130. In the illustrated embodiment, the second volume indicator135 comprises a fluid level indicator 136 and graduations 137. As canreadily be seen in FIGS. 1 and 2 and determined from other disclosuresherein, the fluid level indicator 136 and the graduations 137 can beprinted on the first cover 130 in any suitable manner so as to bereadily visually discernible relative to the adjacent portions of thefirst cover 130, and/or may comprise raised or indented portions thatare readily visually discernable. In the illustrated embodiment, thelines of the graduations 137 are substantially horizontal. Each of thelines of the graduations 137 extends from a linear edge 139 of the fluidlevel indicator 136. In the illustrated embodiment, the linear edge 139is angled (non-perpendicularly) relative to the lines of the graduations137. Moreover, as shown in FIG. 2B, when the covers 130, 140 are in aninitial state (e.g., when the bag 110 is empty), the cover 140 canextend over the linear edge 139, and the inner edge 142 of the cover 140can be angled by a different amount relative to the graduations 137, ascompared with the linear edge 139. The function of second volumeindicator 135 is described in text associated with FIGS. 3A-3B, below.It will be appreciated that in other embodiments, the edge 139 maydefine some contour other than linear.

Second cover 140 may comprise an opaque material that may be identicalto that of the first cover 130. The second cover 140 may comprise anouter edge 141, an inner edge 142, a seam 143, perforations 144, and acutout 148. As with first cover 130, second cover 140 may be coupled tobag 110 along outer edge 141 to form seam 143. Perforations 144 may beformed in cover 140 along the seam 143 such that the cover may be atleast partially removed. In other or further embodiments, a region ofweakness may be defined by or may border the seam 143 such that thesecond cover 140 may be removed generally along the line or contour ofthe seam 143. First and second covers 130 and 140 may be coupled tofluid bag 110 during manufacture of the bag 110. For example, the seams133 and/or 143 may be formed at the same time.

A variety of types and configurations of first and second covers 130,140 may be used without deviating from the spirit of the presentdisclosure. For example, the first and second covers 130, 140 may or maynot be coupled to the lower portion of the fluid bag 110. In other orfurther embodiments, the covers 130, 140 may not extend all the way tothe bottom of the fluid bag 110. First and second covers 130, 140 may beconfigured to be removable without employing perforations; for example,the seams may be configured to rupture when tension is applied for themor reversible (e.g., selectively attachable) fasteners may be used suchas snaps, clips, zippers, hooks and loops closures, or removable glue.The fasteners may instead permanently or non-removably fix the covers130, 140 to the fluid bag 110. The various forms of fastening the covers130, 140 to the bag 110 may additionally or alternatively be used toattach the covers 130, 140 to other portions of the assembly 100. Forexample, in some embodiments, at least a portion of one or more of thecovers 130, 140 may be attached to the hanger 124 in any suitablemanner.

FIGS. 3A-3D depict bodily fluid drainage assembly 100 from a frontelevation view, wherein in FIG. 3A, the assembly does not contain fluid;in FIG. 3B, the assembly has received some fluid; in FIG. 3C theassembly has received some additional fluid; and in FIG. 3D, the secondcover of the assembly has been partially torn away. In the depiction ofFIG. 3A bodily fluid drainage assembly is in an empty, planar (e.g.,flat) configuration. In the illustrated arrangement, the first andsecond covers 130 and 140 hang downwardly so as to cover the front faceof the fluid bag 110. As the covers 130, 140 are opaque, they obscurethe contents of the fluid bag 110. Graduations 137 of the second volumeindicator 135 are visible, but partially obscured by inner edge 142 ofsecond cover 140.

When assembly 100 receives fluid 150, as depicted in FIG. 3B, the fluidbag 110 changes from an unexpanded (e.g., substantially planar)configuration to an increasingly expanded (e.g., more rounded orovalized, in horizontal cross-section) configuration. As a result, thefluid bag 110 may expand more in a central region thereof than it doesnear the seam 113, which can cause the first cover 130 and second cover140 slide over each other in opposing outward directions, such that theposition of inner edge 142 of the second cover 140 is altered relativeto the second volume indicator 135 of the first cover 130. In thedepiction of FIG. 3B, the assembly 100 has received enough fluid thatinner edge 142 has slid far enough that a portion of the fluid levelindicator 136 has become visible. The approximate volume of the liquidmay be determined by identifying among graduations 137 those that areadjacent to the uppermost portion of the fluid level indicator 136 thatis visible before inner edge 142 obscures the fluid level indicator. Assuch, an approximate volume of a fluid within bodily fluid drainageassembly 100 may be ascertained without directly viewing the fluidwithin the fluid bag. In the illustrated embodiment, an approximatefluid volume reading can be obtained from the graduation 137 that isnearest to the intersection of the linear edge 139 of the fluid levelindicator 136 and the inner edge 142 of the second cover 140.

In the depiction of FIG. 3C, assembly 100 has received additional fluid150 such that inner edge 142 of second cover 140 has slid further overthe first cover 130 and second volume indicator 135 in an outwarddirection. Inner edge 142 thus has revealed more of fluid levelindicator 136, such that a new approximate volume is indicated by thefluid level indicator 136, graduations 137 and inside edge 142 of secondcover 140 in a manner such as described above. As shown in FIG. 3C,inner edge 142 has slid across fluid level indicator 136 to reveal theindicator up to the approximate level of fluid 150.

FIG. 3D depicts assembly 100 as shown in FIG. 3D after a portion ofsecond cover 140 has been removed. If a person would like to directlyobserve fluid 150 through front panel 112 of bag 110, second cover 140may be partially or completely removed from assembly 100 via rupturingperforations 144. In the depiction of FIG. 3D, a portion of second cover140 has been torn from assembly 100 to form a flap 145. Likewise, firstcover 130 may be partially or completely removed such that thegraduations 118 (see FIG. 1) located on front panel 112 may be used toestimate the volume of the fluid contained within bag 100. Fluid 150 maybe temporarily visualized without removing first cover 130 and/or secondcover 140 by lifting a bottom portion of the cover(s). As previouslymentioned, in other embodiments, one or more of the covers 130, 140 maynot include the rupturing perforations 134, 144, and may instead beremoved, for example, along paths that border the seams 133, 143.

FIGS. 4A-4D depict another embodiment of a bodily fluid drainageassembly 200. Assembly 200 may be configured similarly and may functionsimilarly as assembly 100, described herein in certain respects.Accordingly, like features may be designated with like referencenumerals, with the leading digits incremented to “2.” Relevantdisclosure set forth above regarding similarly identified features thusmay not be repeated hereafter. Moreover, specific features of theassembly 200 may not be shown or identified by a reference numeral inthe drawings or specifically discussed in the written description thatfollows. However, such features may clearly be the same, orsubstantially the same, as features depicted in other embodiments and/ordescribed with respect to such embodiments. Accordingly, the relevantdescriptions of such features apply equally to the features of theassembly 200. Any suitable combination of the features and variations ofthe same described with respect to the assembly 100 can be employed withthe assembly 200, and vice versa. This method of disclosure also appliesto the additional embodiments discussed further below.

Drainage assembly 200 may comprise a fluid bag 210, a first cover 230, asecond cover 240, and a third cover 260. Fluid bag 210 may comprise anouter edge 211, a front face 212, a seam 213, an upper portion 215, alower portion 216, a first volume indicator 217, an inlet tube 221, anoutlet tube 222, and a hanger 224.

Fluid bag 210 may comprise one or more pieces of plastic material thatare coupled together to form a bag that can retain fluid that has anouter edge 211 that defines a perimeter of the bag. Adjacent to theouter edge is a seam 213 that may be formed by coupling the one or moreplastic pieces together via RF welding or any other suitable technique.In the depicted embodiment, an inlet tube 221 and hanger 224 are locatedon an upper portion 215 and an outlet tube 222 is located on a lowerportion 216 of fluid bag 210. At least a portion of fluid bag 210 may beat least partially transparent; for example, at least a portion of frontface 212 may be transparent, such that various characteristics of afluid contained within the fluid bag may be determined. First volumeindicator 217 may be printed, stamped, or otherwise marked on fluid bag210. In the depicted embodiment, first volume indicator 217 comprisesgraduations that demark approximate volumes of a fluid contained withinthe fluid bag.

First cover 230 may comprise an opaque or at least partially opaquematerial that is coupled to fluid bag 210. First cover 230 may comprisean outer edge 231, an inner edge 232, a seam 233, perforations 234, anda second volume indicator 235. Second volume indicator may comprise afluid level indicator 236 and graduations 237. Second cover 240 maycomprise an outer edge 241, an inner edge 242, a seam 243 andperforations 244. Third cover 260 may comprise a window cover 261, awindow 262, a cutout 263, perforations 264, and outer edges 265.

FIG. 4B depicts bodily fluid bag assembly 200 after the assembly hasreceived some fluid 250. Second volume indicator 235 may be configuredto function similarly as second volume indicator 135, except that thefirst cover 230 cooperates with the third cover 230 in revealing thefluid level indicator 236. As assembly 200 receives fluid 250, fluid bag210 may expand and cause the third cover 260 and first cover 230 toslide over each other such that fluid level indicator 236 becomesvisible. A left outer edge 265 of the third cover 260 thus can operatein a manner similar to the inner edge 142 of the second cover 140discussed above. The topmost visible portion of fluid level indicator236 may correspond with a top level of fluid 250 such that anapproximate volume can be determined by correlating the topmost visibleportion of fluid level indicator 236 with the nearest graduation 237.

As depicted in FIGS. 4B-4C, third cover 260 may comprise a window cover261, a cutout 263, and perforations 264. Window cover 261 may comprise aremovable opaque plastic that is the same material from which cover 260is formed. When window cover 261 is removed, a portion of transparentwindow 262 is revealed such that a level of the fluid 250 can bedetermined. Window 262, when opened in this manner, thus may reveal aportion of the transparent or translucent front face 212 of fluid bag210 that is positioned between, and not covered by, the opaque first andsecond covers 230 and 240. Accordingly, if desired, a practitioner canremove the window cover 261 so as to reveal a thin strip of the clear orsemi-clear portion of the bag 210, and thereby provide another visualindicator of the fill level 250 of fluid within the bag 210. It is notedthat the cutout 263 can be shaped and sized to accommodate the junctionof the inlet tube 221 and the bag 210.

FIG. 4D depicts bodily fluid drainage bag assembly 200 after third cover260 has been removed and first and second covers have been partiallyremoved. First volume indicator 217 may be used to find an approximatevolume of fluid 250. For example, this determination can be achieved bytemporarily lifting, or even by removing, second cover 240. First andsecond covers 230 and 240 may be removed by rupturing perforations 234and 244 such that front face 212 is entirely revealed and at least theportion of fluid 250 nearest the front face 212 of the fluid bag can bevisualized.

FIGS. 5A-5C depict another embodiment of a bodily fluid drainage bag 300from front elevation views, wherein FIG. 53A depicts the assembly, FIG.5B depicts the assembly after the assembly has received some fluid, andFIG. 5C depicts the assembly after a portion of the assembly has beenremoved. Assembly 300 may be configured similarly and may functionsimilarly as assemblies 100 and/or 200 described herein. Assembly 300may comprise a fluid bag 310, an inlet tube 321, an outlet tube 322, ahanger 324, and a cover 330.

Fluid bag 310 may comprise an outer edge 311, a front face 312, a firstvolume indicator 317, a left portion 318, and a right portion 319. Outeredge 311 may comprise a perimeter of fluid bag 310 and may at leastpartially comprise a seam formed by coupling one or more panels ofplastic material together to form the fluid bag. Front face 312 maycomprise an opaque left portion 318 and a transparent right portion 319.Left and right portions 318 and 319 are defined strictly for descriptivepurposes and the portions themselves and features associated with themmay be exchanged or flipped. Left and right portions may or may notdefine half or approximately half of fluid bag 310 front face 312.

Front face 312 of fluid bag 310 may comprise a transparent ortranslucent plastic material. Right portion 319 is at least partiallytransparent, except for first volume indicator 317, which may be printedon the right portion. First volume indicator 317 comprises graduationsthat allow for an approximate volume of a fluid within the bag. Anopaque cover 330 is coupled to fluid bag 310 such that the transparentright portion 319 is obscured. Left portion 318 may be rendered opaqueby printing, painting, or any other suitable technique and at least aportion of second volume indicator 335 may be printed on the leftportion.

Cover 330 may comprise an outer edge 331, an inner edge 332, a seam 333,and perforations 334. Cover 330 comprises an opaque material that iscoupled to fluid bag 310 to form seam 333, wherein outer edge 331 is atleast partially aligned with a perimeter of the fluid bag. Perforations334 may be formed in cover 330 such that the cover may be removed fromassembly 300 to reveal right portion 319 and first volume indicator 317.

FIG. 5B depicts assembly 300 after the assembly has received a volume offluid 350. Cover 330 is configured to slide over right portion 318 ofbag 310 such that a portion of fluid level indicator 336 is revealed,wherein a topmost revealed portion of the fluid level indicatorcorresponds to the level of fluid 350. An approximate volume of fluid350 may be ascertained by locating a graduation 337 that is adjacent tothe topmost revealed portion of fluid level indicator 336. As such, anapproximate volume of fluid 350 may be determined without directlyviewing fluid 350.

FIG. 5C depicts assembly 300 after cover 330 has been removed such thattransparent or translucent right portion 319 of front face 312 isvisible. An approximate volume of fluid 350 can be determined bycomparing the top of the fluid to the nearest graduation on first volumeindicator 317. Graduations 337 of second volume indicator 335 may or maynot report an accurate approximate volume, when compared directly to thetop level of fluid 350.

FIGS. 6-8 depict alternative embodiments of bodily fluid drainageassemblies from front elevation views, wherein FIG. 6 depicts assembly400; FIG. 7 depicts assembly 500; FIG. 8 depicts assembly 600: and FIG.9 depicts assembly 700. Assemblies 400, 500, 600, and 700 may beconfigured similarly and may function similarly as assemblies 100, 200,and/or 300 described herein. Assembly 400 may comprise a fluid bag 410,a first cover 430, and a second cover 440. Assembly 400 may furthercomprise an inlet tube, an outlet tube, and first and second volumeindicators as described herein.

Likewise, assembly 500 may comprise a fluid bag 510, a first cover 530,and a second cover 540. Assembly 500 may further comprise an inlet tube,an outlet tube, and first and second volume indicators as describedherein. Assembly 600 may comprise a fluid bag 610, a first cover 630,and a second cover 640. Assembly 600 may further comprise an inlet tube,an outlet tube, and first and second volume indicators as describedherein. Assembly 700 may comprise a fluid bag 710, a first cover 730,and a second cover 740. Assembly 700 may further comprise an inlet tube,an outlet tube, and first and second volume indicators as describedherein.

FIGS. 10-11 depict another embodiment of a bodily fluid drainageassembly 800 from a front elevation view. Assembly 800 may be configuredsimilarly to and may function similarly as other bodily fluid drainageassemblies described herein. Assembly 800 may comprise a fluid bag 810,a first cover 830, and a second cover 840. Assembly 800 may furthercomprise an inlet tube 821, an outlet tube (not shown) and a hanger 824.The outlet tube may be configured similarly to outlet tube 122,described herein, except that in the depicted embodiment of assembly800, the outlet tube is located on a rear face of fluid bag 810. Inanother embodiment, the outlet tube of assembly 800 is located on afront face of the fluid bag 810, and in yet another embodiment, theassembly does not comprise an outlet tube. Additionally, if an outlettube is present on assembly 800, the outlet tube may comprise an outletregulator, as is well known in the art.

Fluid bag 810 may comprise one or more pieces of material coupledtogether such that a front and a rear face are formed. Front face 812and a rear face (not shown) may be coupled together at a seam that maybe located adjacent to an outer edge of the fluid bag. A first volumeindicator 817 may be located on a face of fluid bag 810 such that anapproximate volume of a liquid 850 may be appreciated. In the depictedembodiment, first volume indicator 817 is located on front face 812.

One or more panels of material may be coupled to the fluid bag toobscure or at least partially obscure the contents of the fluid bag.First cover 830 and second cover 840 are two such panels, and maycomprise opaque pieces of a plastic or fabric material. First and secondcovers 830 and 840 may be coupled to fluid bag 810 via seams 833 and843. Perforations 834 and 844 may be formed in any portion of firstand/or second cover 830 and 840 such that one or both of the covers canbe removed from the fluid bag. In the depicted embodiment, perforations833 and 843 are located adjacent to seams 834 and 844 such that if thecovers are removed via the perforations, a majority of the covers areremoved from the fluid bag.

The covers may function together to form a second volume indicator 835,which works similarly to those described herein, wherein the first andsecond covers 830, 840 slide over each other as the volume of the fluidin the fluid bag increases. An approximate volume may be appreciated byidentifying the point at which the two covers overlap at their insideedges 832 and 842 and comparing that point to a scale 837, or second setof graduations, which can be located on one or more of the covers. Inthe depicted embodiment, the scale 837 is located on cover 840.

Removable portions 861 may comprise areas defined by perforations,wherein upon rupturing the perforations, a user may remove the removableportions thereby allowing direct visualization of a fluid within thefluid bag. When removed, removable portions may be said to form windowsin the cover and each window may be formed in a predetermined locationsuch that it may be used to appreciate a minimum volume of fluid in thefluid bag. As such, the removable portions 861 and/or the windows thatare formable by removing the portions 861 may be said to define a thirdvolume indicator.

In the depicted embodiment, the first cover is depicted as lyingunderneath the second cover; however, one skilled in the art willappreciate that the relationship may be reversed. Also, the removablewindows are depicted as being on the second cover, whereas in otherembodiments, the windows may be located on the first cover or on bothcovers.

A gap 870 is defined by inner edges 832 and 842 of the first and secondcovers 830 and 840 of material. Gap 870 is formed because the covers donot overlap along their entire length. Gap 870 may be employed as afourth volume indicator, which may also be called a “gap volumeindicator”. If the volume of fluid is greater than, for example, about1500 milliliters in the illustrated embodiment, then the second volumeindicator may not continue to function; however, the fluid level will bevisible within gap 870 (the fourth volume indicator) such that the fluidlevel can be compared to a scale printed on one of the covers. In thisway, an approximate volume can be appreciated via gap 870 if the fluidvolume is greater than a predetermined value. The volume at which secondvolume indicator 865 ceases to function and the fourth volume indicatorbegins to function may be any predetermined value.

FIG. 11 depicts assembly 800 from a front elevation view after first andsecond covers 830 and 840 have been lifted to reveal front face 812 offluid bag 810, as well as first volume indicator 817, second volumeindicator 835, and gap 870. Note that perforations 833 and 843 have notbeen ruptured and as such, the covers 830 and 840 have not been removedfrom the assembly; rather, the covers have been lifted. With the coverslifted, an approximate volume of fluid 850 may be appreciated via firstvolume indicator 817, which in this embodiment comprises a scale locatedon front face 812 of fluid bag 810.

FIG. 12 depicts another embodiment of a bodily fluid drainage assembly900 from a front elevation view. Assembly 900 may be configuredsimilarly to and may function similarly as other bodily fluid drainageassemblies described herein. Assembly 900 may especially be similar toassembly 800, which is described herein. Assembly 900 may comprise afluid bag 910 with a front face 912, a first cover 930 and a secondcover 940. An inlet tube 921 and an outlet tube (not visible) maycontrol fluid 950 inflow and outflow. A hanger 924 may be directlyattached to fluid bag 910. Assembly 900 may comprise a first volumeindicator 917, a second volume indicator 935, and a gap volume indicator970. Gap 970 is defined by inner edges 932 and 942. The configurationsand functions of these features have been described elsewhere herein.

First and second covers 930 and 940 may comprise a semitransparent ortranslucent plastic material, such as a clear material that is frosted.In another embodiment, the covers comprise a transparent material thathas been colored as to render it semitransparent or transparent butwherein the fluid appears to have an altered color when viewed throughone of the covers. In another embodiment, one of the covers issemitransparent and the other panel is opaque. As with other coversdescribed herein, covers 930 and 940 may be removably coupled to fluidbag 910 at seams 933 and 943. In the depicted embodiment, covers 930 and940 may be removed via the rupturing of perforations 934 and 944.

FIG. 13 is a perspective view of another embodiment of a bodily fluiddrainage assembly 1000. Assembly 1000 may comprise a fluid bag 1010 anda cover 1030. Fluid bag 1010 may be configured similarly and mayfunction similarly as other fluid bags described herein. For example,fluid bag 1010 may comprise an at least partially translucent materialwith volume markings indicated such that a fluid contained within thefluid bag may be visualized and an approximate volume estimated.Assembly 1000 may also comprise an inlet tube, outlet tube, outletregulator, and/or a hanger, as described previously herein.

Cover 1030 may comprise a first volume indicator 1017 and a secondvolume indicator 1035. Cover 1030 may comprise a printed or opaquematerial, such as a plastic material, which obscures visualization of afluid contained within fluid bag 1010. First volume indicator 1017 maycomprise a window 1062 through which a fluid contained in fluid bag 1010may be visualized. First volume indicator 1017 may also comprisegraduations that indicate approximate volumes. Window 1062 may comprisea removable or cutout portion of cover 1030. If a meniscus or top levelof a liquid contained within fluid bag 1010 is visible within window1062, an approximate volume of the liquid can be ascertained bycomparing the level of the fluid with an adjacent graduation. Window1062 is depicted as being an elongated slot; however, those skilled inthe art will recognize that the window may comprise any shape and itssize can also vary.

Second volume indicator 1035 may comprise a cutout 1038 and graduations.Cutout 1038 may comprise a removable or cutout portion of cover 1030. Ifa level of a liquid contained within fluid bag 1010 is visible withincutout 1038, an approximate volume of the liquid can be ascertained bycomparing the level with an adjacent graduation. Cutout 1035 is depictedas a “V” shape; however, those skilled in the art will recognize thatthe shape of the cutout may vary. Further, the size of the cutout maydiffer from the depiction.

Cover 1030 may be coupled to fluid bag 1010 at a seam 1033. Seam 1033may be formed via RF welding, gluing, melting, stitching or any othersuitable technique. Seam 1033 may include a weakened area that acts likea perforation, so that cover 1030 may be at least partially removablefrom fluid bag 1010, as described for other covers described herein.Seam 1033 may be formed on one or more sides of assembly 1000. In thedepicted embodiment, seam 1033 is formed along a portion of a top sideof fluid bag 1010 and cover 1030. As depicted in FIG. 13, if cover 1030is not coupled to the fluid bag along one or more adjacent sides, thecover may be at least partially lifted such that the fluid bag can bedirectly viewed.

FIG. 14 is a perspective view of bodily fluid drainage assembly 1000, asdepicted in FIG. 13, except that in the depiction of FIG. 14, cover 1030is not lifted, or stated otherwise, is draped downward. As describedabove, assembly 1000 may comprise a fluid bag 1010, and a cover 1030.Cover 1030 is depicted as having a first and a second volume indicator1017 and 1035. The first volume indicator may comprise a window 1062.Second volume indicator 1035 may comprise a cutout 1038. Each of thewindow 1062 and the cutout 1038 may be referred to as openings definedby the cover 1030.

FIGS. 15-16 depict cover 1030 of assembly 1000 from a front and sideelevation view respectively. Cover 1030 comprises a first and secondvolume indicator 1017 and 1035. The first volume indicator may comprisea window 1062. Second volume indicator 1035 may comprise a cutout 1038.Cover 1030 is configured to cover fluid bag 1010. In the depictedembodiment, the cover overlaps the fluid bag on lateral sides and isapproximately even with the fluid bag on the top and bottom sides. Inanother embodiment, the bottom of the cover that is opposite cutout 1038extends beyond a bottom edge of the fluid bag. As depicted in FIG. 16,cover 16 may define a substantially planar shape. The 1030 cover can beflexible, pliable, compliant, or yielding so as to be readily moved froma generally planar shape to a curved shape for temporary viewing.Similarly, the cover 1030 may be able to curve somewhat about the fluidbag 1010 as the bag 1010 fills with fluid and becomes more rounded orovoid (in horizontal cross-section).

FIGS. 17-20 depict another embodiment of a bodily fluid drainageassembly 1100 that resembles those discussed above in many respects,particularly the bodily fluid drainage assembly 1000. As previouslyindicated, appropriate portions of the foregoing discussion regardingother embodiments of bodily fluid drainage bag assemblies, theircomponents, and their related methods are equally applicable to theassembly 1100, and vice versa. The assembly 1100 includes a fluid bag1110 and a cover 1130. In FIGS. 17 and 18, the assembly 1100 is shown ina pre-use or unfilled state, in which the fluid bag 1110 is empty, void,or unfilled. In FIG. 17, the cover 1110 is shown in an obscuring (e.g.,draped or lowered) orientation. In FIG. 18, the cover 1110 is shown in aviewing (e.g., raised) orientation. In FIGS. 19 and 20, the cover 1110is shown in the obscuring orientation and the fluid bag 1110 ispartially filled. The assembly 1110 is thus in a collection or fillingstate. These operational orientations of the assembly 1100 and itscomponents are discussed further below.

The assembly 1100 is configured to receive a bodily fluid, optionallyretain the fluid, and obscure the visibility of at least a portion ofthe fluid when it is within the fluid bag 1110. This can be desirable ina variety of settings. For example, in some embodiments, the fluid bag1110 may be used to collect urine from a patient, and use of the cover1130 to obscure a large portion of the collected urine can maintain thedignity of the patient. Moreover, an approximate volume of the bodilyfluid that is within the fluid bag 1110 can be determined while theassembly 1100 is maintained in the obscuring orientation.

The fluid bag 1110 can be constructed in any suitable manner, such asthose discussed above. With reference to FIGS. 17, 18, and 20, in theillustrated embodiment, the fluid bag 1110 includes a front panel 1112 aof flexible material and a rear panel 1112 b of flexible material. Anysuitable material, may be used, such as a plastic (e.g., polyvinylchloride, polyurethane, vinyl). The front and rear panels 1112 a, 1112 bare joined to each other so as to form a fluid-tight seal. For example,the panels 1112 a, 1112 b can be sealed to each other at or near anouter edge 1111 of the fluid bag 1110. The seal may be formed by one ormore seams 1113 that extend about a periphery of the fluid bag 1110,which can be formed by RF welding, ultrasonic welding, heat sealing, orthe like. In the illustrated embodiment, the rear panel 1112 b is opaqueand the front panel 1112 a is transparent or semitransparent. As usedherein, the term “semitransparent” is a broad term used in its ordinarysense and includes such properties as translucency. Accordingly, whenthe cover 1130 is raised (as in FIG. 18) such that the front panel 1112a is visible, the contents of the fluid bag 1110 can be readilydiscerned when the bag 1110 is viewed from a position in front of theassembly 1100. It is noted that a front face of the front panel 1112 aand a rear face of the rear panel 1112 b define an outer surface of thefluid bag 1110, and a rear face of the front panel 1112 a and a frontface of the rear panel 1112 b define an inner surface of the fluid bag1110. In the illustrated embodiment, a volume indicator 1117, whichincludes graduated volume markings or graduations 1118, is positioned onthe front face of the front panel 1112 a. For example, in theillustrated embodiment, the volume indicator 1117 is printed onto thefront panel 1112 a.

With reference to FIG. 17, a hanger 1124 can be attached to the fluidbag 1110 in any suitable manner. In the illustrated embodiment, a lowerportion 1126 of the hanger 1124 is positioned within a non-fillableportion 1125 of the fluid bag 1110, which is formed by creatingadditional seams 1113 between the front and rear panels 1112 a, 1112 b.The hanger 1124 is thus permanently fixed to the bag 1110. In theillustrated embodiment, the hanger 1124 defines two apertures 1127through which strings (not shown) may be threaded to assist in steadyingthe assembly 1100, or to be used as an alternative to the hookedportions of the hanger 1124 for attaching the assembly 1100 to a desireddevice (e.g., hospital bed or stand).

As with other assemblies described herein, the fluid bag 1110 can becoupled with an inlet fluid line 1190 through which a bodily fluid isreceived from a patient. In some embodiments, the fluid bag 1110 canfurther be coupled with an outlet fluid line 1192 through which fluidcan be expelled from the fluid bag 1110. In the illustrated embodiment,the inlet fluid line 1190 is positioned at an upper end 1115 of thefluid bag 1110 and includes an inlet tube 1121 that is coupled with avalve assembly 1128, which can include a drip chamber and an anti-refluxvalve. The valve assembly 1128 can deliver fluid into the fluid bag 1110through an inlet opening 1129. The outlet fluid line 1192 is positionedat a lower end 1116 of the fluid bag 1110 and includes an outlet tube1122, which may include an output regulator 1123. The fluid bag 1110 mayfurther comprise an outlet tube holder 1114, such as a slot, loop, orhook that is configured to receive and reversibly retain outlet tube1122 in an at least partially upright position, such as when theassembly 1100 is in a packaged or pre-use state.

The cover 1130 can include a volume indicator 1135 such as variousvolume indicators described above. The illustrated volume indicator 1135includes a window 1180 and one or more graduations 1137. A variety ofconfigurations for the window 1180 and the graduations 1137 arepossible. For example, a variety of shapes are possible for the window1180, and the number and arrangement of the graduations 1137 may bevaried. In the illustrated embodiment, the window 1180 defines apermanent opening through the cover 1130 and is fully encompassed bysolid or unbroken portions of the cover 1130. The window 1130 defines asmall, vertically oriented longitudinal slot. Only a small portion ofthe front face of the fluid bag 1110 is visible through the window 1180when the cover 1130 is in the obscuring orientation. An approximatevolume level can be determined when a top level of the bodily fluid isvisible through the window 1180, such as by comparing the level of theliquid to the graduations 1137. Due to the fixed relationship betweenthe upper end of the cover 1130 and the fluid bag 1110, the graduations1137 can provide an accurate assessment of the approximate liquid volumewhen the cover 1130 hangs downwardly.

In the illustrated embodiment, the window 1180 may be oriented such thata portion of the graduations 1118 that are on the fluid bag 1110 arevisible through the window 1180 when the cover 1130 is in the obscuringorientation. In certain embodiments, the bag graduations 1118 may beoffset relative to the cover graduations 1137 when the fluid bag 1110 isdevoid of fluid. The offset can account for relative movement betweenthe cover 1130 and the fluid bag 1110 as the bag fills with fluid. Inparticular, as shown in FIG. 20, the fluid bag 1110 can transition froma generally flat configuration to an outwardly expanded or bowedconfiguration as it fills with the bodily fluid 1151, and in somearrangements, the cover 1130 may not strictly match the contour of thebag 1110 as the bag expands. This relative shift in positions can causethe graduations 1180 of the volume indicator 1135 to come into greateralignment with the graduations 1118 of the volume indicator 1117.

In the illustrated embodiment, the cover 1130 includes an additionalvolume indicator 1149. The volume indicator 1149 includes a recess, suchas a notch or cutout 1138, and a set of graduations 1147. A bottom endof the cutout 1138 is at a position that is horizontally offset andspaced vertically from an upper end of the window 1180. Due to thedifference in vertical positions between the cutout 1138 and the window1180, the top level 1150 of the bodily fluid 1151 can remain below thecutout 1138 at all times that the window 1180 is used in determining theapproximate volume of the fluid 1151, and the top level 1150 of thebodily fluid 1151 can remain above the window 1180 at all times that thecutout 1138 is used in determining the approximate volume of the fluid1151. Accordingly, due to the relative vertical positions of the cutout1138 and the window 1180, determining that a top level of a fluid isviewable through one or the other of the cutout 1138 and the window 1180can provide a quick and convenient visual indication of a general filllevel of the fluid bag 1110, which may be on a rougher scale than thatprovided by the graduations 1137, 1118 (e.g., ½ full, ⅔ full, ¾ full,etc., rather than a specific number of milliliters).

Each of the window 1180 and the cutout 1138 may be referred to as anaperture or opening in the cover 1130 through which a portion of thefront panel 1112 a of the fluid bag 1110 may be directly viewed. Thewindow 1180 and the cutout 1138 may be formed in any suitable manner,such as, for example, by stamping, cutting, or punching.

A comparison between the obscuring orientation shown in FIG. 17 and theviewing orientation shown in FIG. 18 demonstrates that a greater portionof the front panel 1112 a of the fluid bag 1110 is directly viewablefrom vantage point, or viewing position, that is in front of theassembly 1100 when the cover 1130 is in the viewing orientation.Accordingly, a practitioner may at times wish to lift the cover 1130 togain a better view of the bodily fluid 1151 that has been collected inthe fluid bag 1110. The cover 1130 may be lifted only partially, asshown in FIG. 18, or may be lifted fully so as to expose an entirety ofthe front panel 1112 a. Moreover, in some instances, a practitioner maydesire to transition the assembly 1100 to an “exposed orientation” bycompletely removing the cover 1130.

It is noted that the term “obscuring orientation,” when used withrespect to the cover 1130, does not necessarily connote that an entiretyof the front panel 1112 a is obscured (e.g., blocked or guarded fromview, rendered difficult to view, or provided with a significantlyaltered appearance) by the cover 1130. Indeed, as demonstrated by theembodiment depicted in FIG. 17, restricted portions of the front panel1112 a can be viewed, observed, or visualized through the window 1180and the cutout 1138 when the cover 1130 is in the obscuring orientation.

The cover 1130 can be attached to the assembly 1100 in any suitablemanner.

In the illustrated embodiment, the cover 1130 is fixedly attached to thebag 1110 along two separate cover seams 1133, which extend along anupper edge of the cover 1130 and continue a short way down opposing sideedges of the cover 1130. In some embodiments, the cover seams 1133 maybe positioned directly on top of the bag seams 1113. In otherembodiments, the cover seams 1133 may extend alongside or spaced fromthe bag seams 1113. For example, the cover seams 1133 may be positionedslightly above a bag seam 1113 (not shown) that defines an upper edge ofthe fillable void or chamber portion of the fluid bag 1110 such that thebag seams 1113 and cover seams 1133 are separate from each other. Suchan arrangement may facilitate removal of the cover 1130 withoutdisrupting the bag seams 1113. As previously discussed with respect toother embodiments, the cover seams 1133 may provide an area or region ofweakness along which the cover 1130 may be readily removed from theassembly 1100, if desired. Other regions of weakness (e.g.,perforations) may also be used.

In some methods of manufacturing the assembly 1100, the bag seams 1113may be formed at a different time from (e.g., before) formation of thecover seams 1133. In other embodiments, the seams 1113, 1133 may beformed simultaneously.

The cover 1130 may be said to be integral with the assembly 1100. Forexample, in some embodiments, the assembly 1100 is sterilized andpackaged with all of the components shown in FIG. 17. While it may bepossible to remove the cover 1130 from the assembly 1100, as justdiscussed, the cover 1130 is nevertheless a fixed and permanentcomponent of the assembly 1100. For example, in the illustratedembodiment, if the cover 1130 is removed by pealing it along its regionof weakness, a portion of the cover 1130 (generally the portion that isattached to the front panel 1112 a by the cover seam 1133) neverthelessremains attached to the fluid bag 1110. In other embodiments, the cover1130 can be selectively attachable to and detachable from the assembly1100, such as with snaps, hook-and-loop fasteners, adhesives, or anyother suitable temporary fastening system. For example, the fastenerscan be positioned along an upper edge of the cover 1130 (e.g., at one ormore positions along the path defined by the seam 1133 in theillustrated embodiment).

As previously mentioned, the cover 1130 is attached to the assembly atan upper end of the assembly 1100. In particular, the cover 1130 isattached to the upper end of the bag 1110. The cover 1130 thus naturallyhangs or drapes downward so as to be positioned in front of the frontface of the front panel 1112 a. The cover 1130 thus conceals or obscuresviewing of a large portion of the front panel 1112 a, where the assemblyis viewed from a position in front of the assembly 1100. In otherembodiments, the cover 1130 may be attached to portions of the hanger1124 and extend downwardly therefrom. In still other embodiments, thecover 1130 may by attached at other sides of the fluid bag 1110. Forexample, in some embodiments, a lower end of the cover 1130 may beattached at a bottom end of the fluid bag 1110 and an upper end of thecover 1130 may be selectively attached and detached from the assembly1100 at or near the upper end 1115 of the fluid bag 1110. Such selectiveattachment and detachment may be achieved in any suitable manner, suchas via snaps, hook-and-loop fasteners, adhesives, or other suitablefastening system.

With reference to FIGS. 18 and 20, the transparent or semitransparentfront panel 1112 a can further include an obscuring pattern 1182, whichmay be positioned in at least the bottom corners of the front panel 1112a. As shown in FIG. 20, the obscuring pattern 1182 can obscure at leasta portion of the bodily fluid 1151 when the assembly 1100 is viewed froma vantage point at a side thereof.

By way of further explanation, in the illustrated embodiment, the cover1130 is formed of a flexible material. When the assembly 1100 is in theunfilled state (e.g., FIGS. 17 and 18), the fluid bag 1100 can besubstantially planar or flat, and the cover 1130 can hang substantiallyvertically and may likewise be substantially planar or flat. The cover1130 may be positioned exclusively forward of the front panel 1112 a,and it may obscure an entirety of the front panel 1112 a (except forthose portions that are visible through the window 1180 and the cutout1138) from all or nearly all vantage points that are forward of theassembly 1100. Moreover, when the assembly is viewed directly from theside at a position where the cover 1130 may not obscure the front panel1112 a, the outer edge 1111 of the bag 1110 is the primarily visibleportion thereof. And since the fluid bag 1110 is void in thisorientation, there is nothing to conceal in any event.

However, as the fluid bag 1110 collects increasing amounts of bodilyfluid 1151, the cover 1130 can be displaced forwardly and may not wraparound the outer sides of the fluid bag 1110, and thus may not concealthe contents of the bag from a side view (see FIG. 20). The obscuringpattern 1182 can aid in concealing the bodily fluid 1151 from such sidevantage points.

Any suitable patterns or shapes may be used for the obscuring pattern1182. In the illustrated embodiment, the obscuring pattern 1182 definesa gradient such that it is darker and opaque at the edges and becomeslighter and translucent at an interior edge thereof. The obscuringpattern 1182 may be printed on the bag 1180 (e.g. silkscreened) orattached thereto in any suitable manner.

FIGS. 21 and 22 illustrate another embodiment of a bodily fluid drainageassembly 1200 that includes a fluid bag 1210 and a cover 1230 thatresemble the fluid bag 1110 and the cover 1130 just described. However,the cover 1230 is configured to provide better concealment of the fluidbag 1210 for side views, as compared with certain embodiments of thecover 1130. The cover 1230 can include one or more darts or pleats 1284that draw the cover 1230 into a rounded, cupped, or convex shape (asviewed from the front). In particular, the pleats 1284 can cause thecover 1230 to define a chamber 1286 that is configured to receive afront panel of the bag 1210 as the bag 1210 expands, as shown in FIG.22. The outer edges of the cover 1230 thus may overlap or curve aboutthe outer edges of the bag 1210 so as to conceal the sides of theexpanded bag 1210.

In the illustrated embodiment, the assembly 1200 is shown in an unfilledor pre-use state in FIG. 21, and is shown in a collection or partiallyfilled state in FIG. 22. As can be appreciated from the shading in FIG.21, the cover 1230 can be non-planar, rounded, or convex when theassembly 1200 is in the pre-use state, as well as when the assembly 1200is in a collection state (FIG. 22).

In the illustrated embodiment, the pleats are formed by cutting a slitat an angle of about 45 degrees relative to a bottom edge of the cover1230 at each of the two bottom corners of the cover 1230. The portionsof the cover 1230 that neighbor a given slit are then overlapped andjoined together in any suitable manner (e.g., via welding, adhesives,etc.). In other embodiments, rather than making a slit at a corner, asmall triangular piece may be removed from the corner, and the portionsof the cover 1230 that neighbor the resultant gap can then be joinedtogether in any suitable manner.

A variety of other suitable arrangements are possible for the cover1230. For example, more or fewer pleats 1286 may be used, and one ormore of the pleats 1286 may be different sizes and/or positioned atdifferent areas about the cover 1230. In the illustrated embodiment, thecontoured cover 1230 is used in place of an obscuring pattern (such asthe obscuring pattern 1182 in FIGS. 18 and 20) at the corners of the bag1230. However, in other embodiments, obscuring patterns may additionallybe used.

FIG. 23 illustrates another embodiment of a bodily fluid drainageassembly 1300 that includes a fluid bag 1310 and a cover 1330. The bag1310 and the cover 1330 include another mechanism for wrapping the sidesof the cover 1330 about the front sides of the bag 1310 so as to conceala transparent or semitransparent portion of the bag 1310 from sideviews. In the illustrated embodiment, both the bag 1310 and the cover1330 include complementary fasteners 1390, 1392 that can be selectivelyattached to each other so as to conceal the side of a filled orpartially filled bag 1310 when the cover 1330 is lowered and in anobscuring orientation. When the fasteners 1390, 1392 are engaged witheach other and the bag 1310 is in a partially filled state, the cover1330 can define a convex shape such as that displayed by the cover 1230in FIG. 22. The fasteners can be selectively detached from each other soas to permit the cover 1330 to be raised to a viewing orientation. Thefasteners can be of any suitable variety (e.g., hook and loop fasteners,snaps, adhesives, etc.). In other embodiments, only one of the bag 1310and the cover 1330 may include one or more fasteners 1390, 1392 (e.g.,resealable adhesives).

A variety of methods for manufacturing and for using bodily fluiddrainage assemblies have been discussed in the foregoing disclosure.Various steps and stages of such methods are provided throughout thediscussion, such that the overall processes for use and manufacture areevident. Certain illustrative methods for using such an assembly arediscussed hereafter, which can serve as an example of the kinds ofmethods that are evident from the foregoing discussion.

Certain methods of using a bodily fluid drainage assembly includeproviding a bodily fluid drainage assembly that comprises a fluid bagand a cover, wherein the fluid bag comprises a front face of which atleast a portion is transparent or semitransparent, and wherein the covercomprises a first volume indicator. Some methods include hanging theassembly such that the cover is positioned in front of the front face ofthe fluid bag so as to thereby obscure from view the at least a portionof the front face that is transparent or semitransparent, and such that,from a vantage point in front of the assembly, the cover obscures fromview every part of the transparent or semitransparent portion that isnot visible through the first volume indicator. Some methods furtherinclude coupling the assembly to a patient via a fluid line so as topermit a bodily fluid to collect within the fluid bag. For example, thefluid line 1190 (FIG. 17) may be coupled with a urinary catheter (e.g.,Foley catheter) that has been inserted into a patient. The methods canfurther include determining an approximate volume of bodily fluid thathas collected within the fluid bag using the first volume indicator.

In some instances, the cover can be configured to transition between anobscuring orientation and a viewing orientation. In certain of suchinstances, determining an approximate volume of bodily fluid isperformed while the cover is in the obscuring orientation. In variousinstances, determining an approximate volume of bodily fluid isperformed without touching, moving, or lifting the cover.

The first volume indicator can be fixed relative to the cover. Forexample, the first volume indicator comprises an opening in the coverthrough which a restricted portion of the front face of the fluid bag isvisible when the cover is positioned in front of the front face of thefluid bag. The first volume indicator can comprises a notch (e.g., thecutout 1138) or a window (e.g., the window 118) in the cover. In otherinstances, the first volume indicator can comprise a fluid levelindicator that is printed on the cover (e.g., a fluid level indicator136, 236).

In some instances, no portion of the front face of the fluid bag isvisible through the first volume indicator from a vantage point in frontof the assembly when the cover is positioned in front of the front faceof the fluid bag. For example, this can be the case where the firstvolume indicator includes fluid level indicators such as the fluid levelindicators 136, 236. In some methods, the assembly comprises anadditional cover that cooperates with the volume indicator to provideinformation regarding an approximate volume of the bodily fluid. Incertain of such methods, prior to determining the approximate volume ofthe bodily fluid that has collected within the fluid bag, the additionalcover is permitted to move relative to the volume indicator as thebodily fluid collects within the fluid bag.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. The same is true with respect to theterms such as “second,” etc. Moreover, any such reference to a “first,”“second,” or other numbered item does not necessarily correspond to the“first,” “second,” or other such numbering of items as set forth in theforegoing description (i.e., the use of such “first,” “second,” and thelike designations is for the sake of convenience and is not necessarilymeant to be limiting).

It is believed that one skilled in the art can use the precedingdescription to utilize the present disclosure to its fullest extent. Itwill be apparent to those having skill in the art that changes may bemade to the details of the above-described embodiments without departingfrom the underlying principles of the disclosure described herein. Inother words, various modifications and improvements of the embodimentsspecifically disclosed in the description above are within the scope ofthe appended claims. The scope of the disclosure is therefore defined bythe following claims.

1. A urinary drainage bag assembly, comprising: a fluid bag including afront panel and a rear panel sealed to each other at or near an outeredge of the fluid bag and having a fillable region and a non-fillableregion; wherein at least a portion of said front panel includes asubstantially transparent or semi-transparent region and a volumeindicator comprising graduations indicating predetermined volumes whichallow a volume of urine within the fillable region to be determined by acomparison between a top of the urine and the graduations; an inlet tubecoupled to an upper portion of the fluid bag; an outlet tube coupled toa lower portion of the fluid bag; a hanger coupled to the upper portionof the fluid bag within the non-fillable region; and an opaque fluid bagcover positioned to obscure at least a portion of the front panel of thefluid bag including the volume indicator, wherein said cover furtherincludes a cutout sized to accommodate a junction of the inlet tube andthe fluid bag.
 2. The urinary drainage bag assembly of claim 1, whereinsaid cutout is shaped to accommodate the junction of the inlet tube andthe fluid bag.
 3. The urinary drainage bag assembly of claim 2, whereinsaid cutout is a V-shape.
 4. The urinary drainage bag assembly of claim1, wherein said cutout is operable to allow direct viewing of at least aportion of the front panel of the fluid bag.
 5. The urinary drainage bagassembly of claim 4, wherein said cover is operable to be flexibly movedfrom a substantially planar shape to a substantially curved shape toallow the direct viewing of at least the portion of the front panel ofthe fluid bag.
 6. The urinary drainage bag assembly of claim 1, whereinsaid cutout is operable to allow access to a portion of the volumeindicator.
 7. The urinary drainage bag assembly of claim 1, wherein saidcutout is operable to allow access to at least one graduation of thevolume indicator.
 8. The urinary drainage bag assembly of claim 1,wherein said cutout allows a determination of the volume of urine in thefluid bag when the volume of urine exceeds a predetermined amount. 9.The urinary drainage bag assembly of claim 8, wherein the predeterminedamount is at least about one of: half full, two-thirds full,three-quarters full, or full.
 10. The urinary drainage bag assembly ofclaim 1, wherein the cutout is positioned at a top edge of the cover.11. The urinary drainage bag assembly of claim 1, wherein said cutoutallows a determination of when the fluid bag is full.
 12. The urinarydrainage bag assembly of claim 1, wherein said cover is operable toallow direct viewing of an entirety of the front panel of the fluid bag.13. The urinary drainage bag assembly of claim 1, wherein said cover isoperable to allow direct viewing of an entirety of the front panel ofthe fluid bag upon lifting the cover.
 14. The urinary drainage bagassembly of claim 1, wherein said cover is operable to be lifted from abottom portion of the cover.
 15. The urinary drainage bag assembly ofclaim 1, wherein said cover is operable to be lifted to reveal at leasta portion of the volume indicator.
 16. The urinary drainage bag assemblyof claim 1, wherein revealing the volume indicator allows the volume ofurine in the fluid bag to be determined.
 17. The urinary drainage bagassembly of claim 1, wherein said cover is removable from the fluid bag.18. The urinary drainage bag assembly of claim 1, wherein said cover isengaged to the fluid bag at or near an upper end of the fluid bag. 19.The urinary drainage bag assembly of claim 1, wherein said cover isremovably engaged to the fluid bag by one or more reversible fasteners,including one or more of snaps, hook-and-loop fasteners, adhesives,clips, zippers, resealable adhesives, or combinations thereof.
 20. Theurinary drainage bag assembly of claim 19, wherein the one or morereversible fasteners are operable to be detached to allow direct viewingof at least a portion of the front panel of the fluid bag.
 21. Theurinary drainage bag assembly of claim 1, wherein said inlet tube iscoupled to the upper portion of the fluid bag with a valve assemblyincluding an anti-reflux valve.
 22. The urinary drainage bag assembly ofclaim 1, wherein said outlet tube includes an output regulator.
 23. Theurinary drainage bag assembly of claim 1, further comprising an outlettube holder configured to reversibly retain the outlet tube in at leasta partially upright position.
 24. The urinary drainage bag assembly ofclaim 1, wherein a base region of said hanger is coupled within thenon-fillable region.
 25. The urinary drainage bag assembly of claim 1,wherein said hanger comprises one or more hook-like extensions orapertures.
 26. The urinary drainage bag assembly of claim 1, wherein abottom of said cover extends beyond a bottom edge of the fluid bag. 27.The urinary drainage bag assembly of claim 1, wherein said cover lacks awindow.